No Drugs Approved for Use in Ferrets: Passage of MUMS May Make it
Easier to Market Drugs for FerretsMay
24, 2004

Washington, DC --- Several vaccines are licensed by
the United States Department of Agriculture labeled for use in ferrets.
But no drugs have been approved for use in ferrets by the Food and
Drug Administration (FDA). One reason for the lack of drug approvals
may be due to the smaller numbers of ferrets in the US, in contrast
to dogs and cats. Currently there are between 7 and 10 million ferrets,
in contrast to the 50 million dogs and 60 million cats in the US.

New pending legislation will change the criteria for drug manufacturers,
making it easier to get drugs approved for ferrets. Under the proposed
“Minor Use and Minor Species Animal Health Act,” (“MUMS”)
[House Bill: HR 2079] ferrets would be considered a “minor”
species. The act would revise the Federal, Food, Drug and Cosmetic
Act under the FDA to provide incentives to drug manufacturers to produce
drugs for animals and for indications that may not be as commercially
rewarding.

MUMS defines “minor species” as not cattle, horses, swine,
chickens, turkeys, dogs, and cats, which are considered to be “major
species” due to their large numbers, making drug indications
for these species very profitable. Disease indications that are uncommon
in these major species are called “minor uses.” Because
of the small market shares, low-profit margins involved, and capital
investment required, it is generally not economically feasible for
new animal drug applicants to pursue approvals for these species,
diseases, and conditions.

Alabama Senator Jeff Sessions introduced the MUMS bill in March
2003 and garnered the support of 21 fellow senators who co-sponsored
the bill, including the Senate's two veterinarians, Wayne Allard of
Colorado and John Ensign of Nevada. FDA Commissioner Mark B. McClellan,
MD, PhD, applauded the Senate action, saying the agency “looks
forward to providing further technical assistance to the House regarding
this legislation.”
Sessions describes MUMS as benefiting “pets and their owners
and ….various endangered species and aquatic animals.”
He says: “The act also will promote the health of all animal
species while protecting human health and will alleviate unnecessary
animal suffering. This is commonsense legislation which will benefit
millions of American pet owners, farmers, and ranchers."

History of MUMS
In 1996, Congress approved the Animal Drug Availability Act (ADAA)
to streamline the animal drug approval process with the goal of increasing
the number of products available to prevent and treat disease in companion
and food animals. The ADAA did not mandate specific changes to improve
the availability of drugs for minor animal species or minor uses,
but it did require the FDA to propose ways this might occur.

In 2001 the American Veterinary Medical Association spearheaded the
process to get legislative relief for drug development in non-“major”
species animals. Forming a coalition of 43 organizations, the AVMA
developed a consensus document that formed the basis for the new legislation.
An AVMA whitepaper states: “Due to the nearly complete absence
of drugs to treat minor species, most animals either go untreated
or treatment is delayed. Delayed treatment is poor treatment; the
result is increased suffering, loss of life and loss of social and
economic value. The emotional and economic impact of these losses
for individual families and the public can be significant.”

MUMS would allow exclusive marketing rights and tax credits for clinical
testing expenses. In addition, the FDA could award federal grants
and contracts to public and private entities and individuals to alleviate
some of the costs of drug testing in these minor species. Similar
to the 1983 Orphan Drug Act for people, which has helped to encourage
the development of drugs for rare human disorders where patient numbers
may be very small, the “Minor Species/Uses Act” should
provide comparable incentives for the development of new animal drugs
for smaller numbers of animals and for rare conditions.

Under MUMS, new animal drugs designated by the FDA for minor species
or minor uses would be eligible to receive “conditional approval”
when the drug is demonstrated to be safe and have a reasonable expectation
of efficacy. This conditional approval, evaluated annually by FDA,
would be limited to five years until full approval is achieved. Included
in the bill is a provision creating a category of index drugs which
would provide for legal use of drugs in “nonfood minor species”
– which includes pets-- for which even conditional approval
is not economically feasible. Most importantly, a MUMS law would provide
legal basis for veterinarians to use such drugs.

Although no drugs are currently approved for use in ferrets, drugs
are routinely used in ferrets under the FDA’s “Extra-Label
Use” provisions. Based on these provisions, drugs labeled for
use in other animals or humans can legally be used in ferrets. However,
the new act should make it easier for drug sponsors to test new animal
drugs for safety and efficacy in ferrets, which would give health
care providers more information on proper dosing, adverse events and
the expected response rates in ferrets.

On March 8, 2004, the bill was passed unanimously by the Senate,
and it is scheduled to be voted on by the House of Representatives.
If it passes, the FDA would be required to issue proposed and then
final regulations on the amended sections of its law. These regulations
would be issued for public comment. To view the House Bill, please
see: http://www.theorator.com/bills108/hr2079.html.

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